MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Codes	Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the backlight does not illuminate on the lcd of the autopulse platform (sn (b)(4)) was confirmed during the functional test.The root cause for the observed lcd issue was a defective processor board, likely attributed to the device's aging.The autopulse platform was manufactured in may 2016 and is over 5 years old, past the expected service life of 5 years.Upon visual inspection, it was noted that the load plate cover was defective with a hole, affecting the watertight seal, unrelated to the reported complaint.This type of physical damage is characteristic of user mishandling.The load plate cover was replaced to address the issue.The autopulse platform passed the initial functional testing without any error.However, the backlight of the display flickers briefly when switched on and goes dark afterwards but display is readable.The root cause for the observed lcd issue was a defective processor board.The processor board needs to be replaced to address this issue.Upon further functional testing and unrelated to the reported complaint, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The root cause was due to the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely due wear and tear.The impact of sticky clutch was not severe enough to make the platform non-functional.Deburring of the clutch plate needs to be performed to remedy the problem.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with sn (b)(4).
Event or Problem Description
During shift check, the backlight does not illuminate on the lcd of the autopulse platform (sn (b)(4)).Per reporter, the display is unreadable when the backlight is not illuminating.No patient involvement.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 12533776
• Report Number: 3010617000-2021-00908
• Device Sequence Number: 1296365
• Product Code: DRM
• UDI-Device Identifier: 00849111002516
• UDI-Public: 00849111002516
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1